# FDA recall Z-1068-2024

> **OriGen Biomedical, Inc.** · Class II · device recall initiated 2023-12-19.

## Product

Accessory Sets Syringes: 6ml syringe with a female luer with 15cm sealed SCD tubing, REF: RF-T15, and 60ml syringe on a female luer with 15cm sealed SCD tubing, REF: 15-RF60-T

## Reason for recall

Accessory sets contain a syringes not yet qualified for the accessory's intended purpose; due to design changes to the syringe barrels and a polypropylene resin change that resulted in loss of gamma compatibility, for accessory set syringes that were gamma sterilized, which resulted in yellowed syringes.

## Distribution

US: FL, WA, NJ, MA, OH, CA, MD, TX, NE, ND  OUS: GB, CA,NL,CH, PL, DE

## Key facts

- **Recall number:** Z-1068-2024
- **Recalling firm:** OriGen Biomedical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-12-19
- **Report date:** 2024-02-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Austin, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1068-2024

## Citation

> AI Analytics. FDA recall Z-1068-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1068-2024. Source: US FDA. Licensed CC0.

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